Medication info
Dutaron Tablet 0.5 mg (Dutasteride)

Dutaron Tablet 0.5 mg (Dutasteride)

Prescription medicationTabletOral
Ingredient · strength
Dutasteride›0.5mg / 1 tablet
Manufacturer / importer
Albogene Korea Co., Ltd.
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201802875 · Approved 2018.07.10 · Insurance code 652606460

Summary

Main use
Treatment of benign prostatic hyperplasia and male-pattern hair loss in adult men (18~50 years)
Who takes it
Adults
Adult dose
The recommended dose of this drug is 1 tablet (0.5mg) once daily. Swallow this drug whole without chewing or splitting it. This drug may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this drug to patients with hepatic impairment.

Ingredients

Manufacturer
Albogene Korea Co., Ltd.

Efficacy & effects

Treatment of benign prostatic hyperplasia and male-pattern hair loss in adult men (18~50 years)

  • Benign prostatic hyperplasia
  • risk of acute urinary retention
  • male pattern baldness
View approved original text

This medication improves symptoms caused by benign prostatic hyperplasia and reduces the risk of acute urinary retention. It also helps to decrease situations requiring surgery related to benign prostatic hyperplasia. Furthermore, it is used to treat male pattern baldness in adult men to enhance hair health. This medicine is effectively used for prostate health and improvement of hair loss.

How to take

Adult dose

The recommended dose of this drug is 1 tablet (0.5mg) once daily. Swallow this drug whole without chewing or splitting it. This drug may be taken with or without food. No dose adjustment is necessary in patients with renal impairment or elderly patients. The recommended dose in patients with hepatic impairment has not been established because there are no data on administration of this drug to patients with hepatic impairment.

Precautions

This medication can be absorbed through the skin, so women who are pregnant or may become pregnant should not handle or touch this medication. Additionally, care should be taken to avoid contact with broken or crushed pieces of this drug. Children should also be kept from touching this medication, and its use in children under 18 years of age is prohibited. Women must not take this medication, and anyone with hypersensitivity to this drug or its components should not use it. Adult men planning to conceive should consult a doctor before using this drug as it may affect fertility. Patients with a high residual urine volume or severe urinary retention should be closely monitored for risk of urinary obstruction when using this medication. Patients with liver dysfunction should use this medication with caution, and care should also be taken when combined with strong CYP3A4 inhibitors. Sexual side effects such as erectile dysfunction, decreased libido, and ejaculation disorders may occur during the use of this medication, and these symptoms may persist even after discontinuation. Other symptoms such as gynecomastia, breast tenderness, and breast enlargement may also appear. Long-term use of this medication may increase the risk of high-grade prostate cancer, so regular prostate cancer screenings are necessary. Patients taking this medication should regularly check serum PSA levels to monitor prostate status. Patients using this drug should not donate blood for at least 6 months after the last dose. There is no specific antidote for overdose, so appropriate supportive therapy should be provided based on symptoms. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality. This drug is known not to affect the ability to drive or operate machinery. Potential interactions with other medications exist; therefore, consult a doctor or pharmacist if taking other medications.

Side effects

  • erectile dysfunction
  • decreased libido
  • ejaculation disorder
  • gynecomastia
  • headache
  • gastrointestinal discomfort and pain
  • sexual dysfunction
  • breast disorders
  • dizziness
  • rash
Show 85 more
  • itching
  • urticaria
  • localized swelling
  • severe skin reactions
  • angioedema
  • depressed mood
  • alopecia
  • hirsutism
  • testicular pain
  • testicular swelling
  • male breast cancer
  • dyspepsia
  • insomnia
  • abdominal pain
  • diarrhea
  • allergy
  • fever
  • congestion
  • thromboembolic stroke
  • lung cancer
  • pulmonary embolism
  • pneumonia
  • dry mouth
  • constipation
  • cramps
  • facial dyskinesia
  • vomiting
  • colonic polyps
  • epigastric discomfort
  • asthenia
  • deep vein thrombosis
  • chills
  • gastroesophageal reflux
  • hemorrhoids
  • pain
  • fatigue
  • increased SGPT
  • rash
  • sexual dysfunction
  • pharyngitis
  • appendicitis
  • fracture
  • viral infection
  • acne
  • fungal dermatitis
  • seborrhea
  • skin disease
  • increased SGOT
  • folliculitis
  • eczema
  • fatty liver
  • chest pain
  • palpitations
  • warts
  • contact dermatitis
  • dry skin
  • peptic ulcer
  • gastritis
  • gastroenteritis
  • drowsiness
  • hyperbilirubinemia
  • upper respiratory infection
  • unspecified abrasion
  • surgical intervention
  • laceration
  • hyperuricemia
  • hypertriglyceridemia
  • weight gain
  • sensory abnormalities
  • decreased testosterone
  • skeletal pain
  • plantar fasciitis
  • bacterial infection
  • purpura
  • nosebleed
  • blepharitis
  • benign laryngeal neoplasm
  • kidney stones
  • dysgeusia
  • capillary dilation
  • visual disturbances
  • thirst
  • urine abnormalities
  • hematuria
  • semen abnormalities

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help to keep the drug's efficacy for a long time.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.